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Primary Responsibilities:This role involves working closely with scientists and regulatory affairs departments on various nonclinical regulatory documents. The Scientific Editor's responsibilities will be:Collaborate with scientists on nonclinical regulatory documents such as Investigator Brochures, Nonclinical Study Reports, Annual Reports, CTAs, INDs, and NDAs. Assume lead scientific writing responsibility on projects, utilizing regulatory and publication documentation expertise.
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Position SummaryThis position is a key leadership role for the development of the In Vivo franchise at CRISPR. Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients.
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Works collaboratively with the Graduate Medical Education (GME) Office and Compliance as necessary to ensure the appropriate fiduciary and regulatory responsibility of education and training programs.
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Reporting to the VP of Program Strategy & Management, this person will work collaboratively to manage and integrate diverse R&D activities including but not limited to, preclinical research, clinical development, CMC, regulatory affairs, new product planning, business development and finance.
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The Senior Director, Model Validation for Santander US Compliance models (Transaction Monitoring, Sanctions Screening, Fraud Risk, etc) will be responsible for leading the independent validation of models used by various Compliance groups in conformance with regulatory guidance on model risk SR11-07 and other regulatory requirements around Compliance models.
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Skilled in writing and supporting the generation of regulatory documents related to Bioanalytical package ( briefing book, assay description, CTD modules for IND/MAA etc) and regulatory interactions ( with FDA CDRH, EU notified bodies.
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A thorough understanding of global drug development functional areas including preclinical, clinical, regulatory affairs and manufacturing. Knowledge of GLP/GCLP and GCP global regulatory requirements for clinical trial submissions (USA, UK & EU), understanding of 21CFR Pt. 11 with respect to clinical systems (QMS.
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Demonstrates compliance with regulatory requirements i.e. MIPS, fall assessment. Comprised of Tufts Medical Center, Lowell General Hospital, MelroseWakefield Hospital, Lawrence Memorial Hospital of Medford, Care at Home - an expansive home care network, and large integrated physician network.
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Lead and synchronize a cross-functional team, including R&D, regulatory affairs, CMC, commercial, and finance to align with program objectives. Comprehensive understanding of the entire drug development process, including in-depth knowledge of regulatory environments, clinical development, Chemistry, Manufacturing, and Controls (CMC), and strategic approaches to commercialization.
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In addition to the Master's in Global Business Administration (GBA), the Fletcher School also offers Master's in Law & Diplomacy (MALD), a Master's in Global Affairs (MGA), a Master's in International Law (LLM), a Master's in International Business (MIB), a Global Master of Arts (GMAP), and a PhD.
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Join Takeda as an Associate Director, Global Regulatory Affairs CMC where you will develop and lead the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products.
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The primary role of the Director, Regulatory Affairs - CMC is to create and/or manage contributions from others for CMC regulatory submission documents. This position reports directly to the Senior Director, Head of Regulatory Affairs - CMC. The Director, Regulatory Affairs - CMC will be responsible and accountable for CMC submission documents while successfully up-holding the vision for the function and help mentoring junior team members.
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Experience in collaborations with medicinal chemistry, analytical, biology, toxicology, clinical pharmacology, Quality Assurance, Regulatory CMC and CMC development departments. Experience in preparation of CMC documents in support of global regulatory filings across development stages (e.g. IND to NDA and IMPD to MMA.
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Senior Regulatory Affairs Manager. External Affairs consists of Communications, Government and Regulatory Affairs, Labor and Workforce Planning, and Community Engagement teams.
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Using an oligonucleotide-based approach, Korro expects to bring its medicines to patients by leveraging its proprietary platform with precedented delivery modalities, manufacturing know-how, and established regulatory pathways of approved oligonucleotide drugs.
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regulatory affairs jobs Title: regulatory affairs project manager Company: Aerotek in Medford, MA
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